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Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank.

Publication ,  Journal Article
Al-Khatib, SM; Calkins, H; Eloff, BC; Kowey, P; Hammill, SC; Ellenbogen, KA; Marinac-Dabic, D; Waldo, AL; Brindis, RG; Wilbur, DJ; Jackman, WM ...
Published in: Am Heart J
October 2010

Although several randomized clinical trials have demonstrated the safety and efficacy of catheter ablation of atrial fibrillation (AF) in experienced centers, the outcomes of this procedure in routine clinical practice and in patients with persistent and long-standing persistent AF remain uncertain. Brisk adoption of this therapy by physicians with diverse training and experience highlights potential concerns regarding the safety and effectiveness of this procedure. Some of these concerns could be addressed by a national registry of AF ablation procedures such as the Safety of Atrial Fibrillation Ablation Registry Initiative that was initially proposed at a Cardiac Safety Research Consortium Think Tank meeting in April 2009. In January 2010, the Cardiac Safety Research Consortium, in collaboration with the Duke Clinical Research Institute, the US Food and Drug Administration, the American College of Cardiology, and the Heart Rhythm Society, held a follow-up meeting of experts in the field to review the construct and progress to date. Other participants included the National Heart, Lung, and Blood Institute; the Centers for Medicare and Medicaid Services; the Agency for Healthcare Research and Quality; the AdvaMed AF working group; and additional industry representatives. This article summarizes the discussions that occurred at the meeting of the state of the Safety of Atrial Fibrillation Ablation Registry Initiative, the identification of a clear pathway for its implementation, and the exploration of solutions to potential issues in the execution of this registry.

Duke Scholars

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

October 2010

Volume

160

Issue

4

Start / End Page

619 / 626

Location

United States

Related Subject Headings

  • United States
  • Safety Management
  • Registries
  • Interprofessional Relations
  • Humans
  • Critical Pathways
  • Catheter Ablation
  • Cardiovascular System & Hematology
  • Atrial Fibrillation
  • 3201 Cardiovascular medicine and haematology
 

Citation

APA
Chicago
ICMJE
MLA
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Al-Khatib, S. M., Calkins, H., Eloff, B. C., Kowey, P., Hammill, S. C., Ellenbogen, K. A., … Krucoff, M. W. (2010). Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank. Am Heart J, 160(4), 619–626. https://doi.org/10.1016/j.ahj.2010.06.044
Al-Khatib, Sana M., Hugh Calkins, Benjamin C. Eloff, Peter Kowey, Stephen C. Hammill, Kenneth A. Ellenbogen, Danica Marinac-Dabic, et al. “Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank.Am Heart J 160, no. 4 (October 2010): 619–26. https://doi.org/10.1016/j.ahj.2010.06.044.
Al-Khatib SM, Calkins H, Eloff BC, Kowey P, Hammill SC, Ellenbogen KA, Marinac-Dabic D, Waldo AL, Brindis RG, Wilbur DJ, Jackman WM, Yaross MS, Russo AM, Prystowsky E, Varosy PD, Gross T, Pinnow E, Turakhia MP, Krucoff MW. Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank. Am Heart J. 2010 Oct;160(4):619–626.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

October 2010

Volume

160

Issue

4

Start / End Page

619 / 626

Location

United States

Related Subject Headings

  • United States
  • Safety Management
  • Registries
  • Interprofessional Relations
  • Humans
  • Critical Pathways
  • Catheter Ablation
  • Cardiovascular System & Hematology
  • Atrial Fibrillation
  • 3201 Cardiovascular medicine and haematology